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Photocoagulator And Accessories

FDA product code HQB · Class 2 · Ophthalmic

515
Registered devices
68
Adverse events
32
Recalls
30
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2025-12-16Vortex Surgical Inc.There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of biob
2025-12-16Vortex Surgical Inc.There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of biob
2025-11-19Vortex Surgical Inc.Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
2025-09-15Alcon Research LLCXXX
2013-12-09Synergetics IncFaulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
2013-12-09Synergetics IncFaulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
2013-12-09Synergetics IncFaulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
2013-12-09Synergetics IncFaulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
2013-12-09Synergetics IncFaulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
2013-12-09Synergetics IncFaulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.